News that the U.S. Trade Representative (USTR) had signed off on a compromise World Trade Organization (WTO) proposal to waive IP rights for COVID-19 vaccines caught Congress by surprise earlier in early May. Now, some members, both Democrats and Republicans, are reminding USTR Katherine Tai that she has an obligation to consult with Congress on such trade issues.
The legislation that would renew a number of FDA user fee programs, the Food and Drug Amendments Act (FDA Act) of 2022, has passed the first legislative hurdle in a subcommittee of the U.S. House of Representatives, but there are several issues with the bill. According to members of the subcommittee, the issues include an absence of provisions for medical device servicing, and the absence of legislation for FDA regulation of lab-developed tests (LDTs), issues that are unlikely to be resolved before the legislation is passed out of the House.
With its focus on transformative high-risk, high-reward research to drive biomedical breakthroughs, the new Advanced Research Projects Agency for Health (ARPA-H) may be a good concept, but it shouldn’t come at the expense of increased investment in basic research at the NIH, according to the bipartisan leadership of U.S. House appropriators.
The U.S. FDA’s efficacy bar for COVID-19 vaccines for the youngest children may be lower than the 50% required for the adult vaccines, according to Peter Marks, director of the agency’s Center for Biologics Evaluation and Research.<
Pharmacy benefit managers (PBMs) were in the spotlight at a May 5 U.S. Senate subcommittee hearing on fairness and transparency in the prescription drug market, but lawmakers indicated they need to turn up the klieg lights of the FTC to penetrate the black box of PBM operations.
The U.S. Centers for Medicare & Medicaid Services’ (CMS) decision last month restricting coverage of a class of Alzheimer’s drugs to clinical trials meeting the agency’s standards still isn’t sitting well with some lawmakers.
Making his first in-person appearance April 27 before the House Energy and Commerce Subcommittee on Health, U.S. Health and Human Services Secretary Xavier Becerra was prepared to answer questions about President Joe Biden’s fiscal 2023 budget that would increase HHS’ discretionary budget to $127 billion, nearly a 27% increase over the 2021 enacted level.
In the second of two hearings before the U.S. Senate Health, Education, Labor and Pensions Committee on the next iteration of the FDA drug and device user fee agreements, the focus was supposed to be on advancing regulation and innovation. But Ranking Member Richard Burr (R-N.C.) shifted the spotlight April 26 to accountability in his opening remarks and subsequent questioning.
The Senate Health, Education, Labor and Pensions (HELP) Committee met April 5 to review the user fee agreements for the drug and device centers, but one member of the committee was quite vocal about the ever-growing volume of user fees. Sen. Richard Burr (R-N.C.) said the pace with which user fees are increasing suggests that the FDA is growing increasingly independent of Congress.
Negotiations between the U.S. FDA and industry over device user fees were a protracted struggle, but the agency was demonstrably loathe to post the minutes from meetings between the agency and industry representatives. Jeff Shuren, director of the FDA’s device center, said in a congressional hearing that those minutes were not posted because of a need to wrap up the negotiations rather than allow outsiders – including members of Congress – to see how difficult the negotiations had become.
